What this study is
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
What's being tested
- Placebo
Intervention · DRUG
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
- iptacopan
Intervention · DRUG
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Study details
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- C3G
- Enrolling
- 98 people
- Starts
- 2021-07-28
- Est. completion
- 2027-01-29
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male and female participants age ≥ 12 and ≤ 60 years at screening.
- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
- Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.
- If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
You can't join if
- Participants who have received any cell or organ transplantation, including a kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
- The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
- A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
- The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
- Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (88)
8 openChildrens Hospital Colorado
Aurora, Colorado, United States
- Kati Dugan · Contact+1 720 777 1234Kati.Dugan@childrenscolorado.org
- Bradley Dixon · Principal investigator
RecruitingNicklaus Childrens Hospital
Miami, Florida, United States
- Moya Chang · Contact+1 305 661 1515Moya.chang@nicklaushealth.org
- Ana Paredes · Principal investigator
RecruitingUniversity of Iowa Health Care
Iowa City, Iowa, United States
- Nicole Gerot · Contact+1 319 335 7555nicole-gerot@uiowa.edu
- Carla Nester · Principal investigator
RecruitingUniversity of Iowa Health Care
Iowa City, Iowa, United States
- Nikki Gerot · Contact+1 (319) 335-0348
- Carla Nester · Principal investigator
RecruitingGeorgia Nephrology Research Inst
Lawrenceville, Georgia, United States
CompletedIN University School of Med
Indianapolis, Indiana, United States
WithdrawnJohns Hopkins Hospital
Baltimore, Maryland, United States
WithdrawnBrigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
WithdrawnHackensack Uni Medical Center
Hackensack, New Jersey, United States
WithdrawnAlbany Medical Center
Albany, New York, United States
WithdrawnCol Uni Med Center New York Presby
New York, New York, United States
CompletedBaylor Scott and White Research
Temple, Texas, United States
WithdrawnUniversity of Wisconsin
Madison, Wisconsin, United States
Withdrawn
75 sites outside the US
Novartis Investigative Site
Recife, Pernambuco, Brazil
RecruitingNovartis Investigative Site
São Paulo, São Paulo, Brazil
RecruitingNovartis Investigative Site
São Paulo, São Paulo, Brazil
RecruitingNovartis Investigative Site
Beijing, China
RecruitingNovartis Investigative Site
Córdoba, Córdoba Province, Argentina
WithdrawnNovartis Investigative Site
Buenos Aires, Argentina
CompletedNovartis Investigative Site
CABA, Argentina
WithdrawnNovartis Investigative Site
Edegem, Belgium
WithdrawnNovartis Investigative Site
Leuven, Belgium
WithdrawnNovartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
WithdrawnNovartis Investigative Site
Passo Fundo, Rio Grande do Sul, Brazil
WithdrawnNovartis Investigative Site
Joinville, Santa Catarina, Brazil
WithdrawnNovartis Investigative Site
Santo André, São Paulo, Brazil
WithdrawnNovartis Investigative Site
São Paulo, São Paulo, Brazil
WithdrawnNovartis Investigative Site
Salvador, Brazil
WithdrawnNovartis Investigative Site
London, Ontario, Canada
CompletedNovartis Investigative Site
Toronto, Ontario, Canada
CompletedNovartis Investigative Site
Montreal, Quebec, Canada
WithdrawnNovartis Investigative Site
Guangzhou, Guangdong, China
Active, not recruitingNovartis Investigative Site
Wuhan, Hubei, China
WithdrawnNovartis Investigative Site
Beijing, China
Active, not recruitingNovartis Investigative Site
Shanghai, China
Active, not recruitingNovartis Investigative Site
Prague, Czechia
CompletedNovartis Investigative Site
Lille, France
CompletedNovartis Investigative Site
Marseille, France
WithdrawnNovartis Investigative Site
Montpellier, France
WithdrawnNovartis Investigative Site
Paris, France
CompletedNovartis Investigative Site
Paris, France
WithdrawnNovartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Active, not recruitingNovartis Investigative Site
Aachen, Germany
WithdrawnNovartis Investigative Site
Erlangen, Germany
CompletedNovartis Investigative Site
Essen, Germany
CompletedNovartis Investigative Site
Hamburg, Germany
CompletedNovartis Investigative Site
Hanover, Germany
WithdrawnNovartis Investigative Site
Heidelberg, Germany
Active, not recruitingNovartis Investigative Site
Mainz, Germany
CompletedNovartis Investigative Site
Athens, Greece
WithdrawnNovartis Investigative Site
Heraklion Crete., Greece
CompletedNovartis Investigative Site
Thessaloniki, Greece
CompletedNovartis Investigative Site
Thessaloniki, Greece
WithdrawnNovartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Active, not recruitingNovartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Active, not recruitingNovartis Investigative Site
Hyderabad, Telangana, India
WithdrawnNovartis Investigative Site
Lucknow, Uttar Pradesh, India
Active, not recruitingNovartis Investigative Site
Dehradun, Uttarakhand, India
WithdrawnNovartis Investigative Site
Petah Tikva, Israel
CompletedNovartis Investigative Site
Petah Tikva, Israel
CompletedNovartis Investigative Site
Ranica, BG, Italy
CompletedNovartis Investigative Site
Milan, MI, Italy
WithdrawnNovartis Investigative Site
Roma, RM, Italy
CompletedNovartis Investigative Site
Nagoya, Aichi-ken, Japan
CompletedNovartis Investigative Site
Asahikawa, Hokkaido, Japan
CompletedNovartis Investigative Site
Sapporo, Hokkaido, Japan
CompletedNovartis Investigative Site
Takatsuki, Osaka, Japan
CompletedNovartis Investigative Site
Ōtsu, Shiga, Japan
CompletedNovartis Investigative Site
Niigata, Japan
CompletedNovartis Investigative Site
Leiden, South Holland, Netherlands
CompletedNovartis Investigative Site
Nijmegen, Netherlands
WithdrawnNovartis Investigative Site
Barcelona, Catalonia, Spain
WithdrawnNovartis Investigative Site
Port de Sagunt, Valencia, Spain
WithdrawnNovartis Investigative Site
Barcelona, Spain
WithdrawnNovartis Investigative Site
Madrid, Spain
CompletedNovartis Investigative Site
Málaga, Spain
WithdrawnNovartis Investigative Site
Seville, Spain
CompletedNovartis Investigative Site
Bern, Switzerland
CompletedNovartis Investigative Site
Lausanne, Switzerland
WithdrawnNovartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
WithdrawnNovartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
WithdrawnNovartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye)
CompletedNovartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
CompletedNovartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
WithdrawnNovartis Investigative Site
Glasgow, Scotland, United Kingdom
WithdrawnNovartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Active, not recruitingNovartis Investigative Site
London, United Kingdom
CompletedNovartis Investigative Site
London, United Kingdom
Active, not recruiting
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CLNP023B12301
Study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.